Phase 3
N=530
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Vaginal Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT01256671 ↗Enrolled (actual)
530
Serious AEs
3.5%
Results posted
Oct 2017
Primary outcome: Primary: Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium — 421; 36 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DHEA (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- EndoCeutics Inc.
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term Safety of Intravaginal Prasterone (DHEA): Endometrium |
421; 36 | — |
| PRIMARY Long-term Safety of Intravaginal Prasterone (DHEA): Serum Steroid Levels |
2071.61; 2997.25; 925.65; 6.05; 4.46; -1.59 | — |
| SECONDARY Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Parabasal Cells). |
55.49; 12.81; -42.67; 63.95; 14.80; -49.14 | — |
| SECONDARY Change From Baseline to Week 52 of Vaginal Cell Maturation (Percentage of Superficial Cells). |
2.02; 9.42; 7.41; 0.96; 8.81; 7.85 | — |
| SECONDARY Change From Baseline to Week 52 of Vaginal pH. |
6.23; 5.09; -1.14; 6.40; 5.13; -1.27 | — |
| SECONDARY Change From Baseline to Week 52 of Self-assessment of VVA Symptom Dyspareunia |
2.53; 0.85; -1.68; 2.57; 0.87; -1.69 | — |
| SECONDARY Change From Baseline to Week 52 of Self-assessment of VVA Symptom Vaginal Dryness |
2.22; 0.59; -1.63; 2.19; 0.67; -1.52 | — |
| SECONDARY Change From Baseline to Week 52 of Self-assessment of VVA Symptom Irritation/Itching |
2.10; 0.60; -1.50; 2.13; 0.74; -1.39 | — |
Summary
The purpose of this Phase III trial is to assess the long-term safety of intravaginal dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal atrophy aged 40 to 75 years.
Eligibility Criteria
Main Inclusion Criteria:
- Postmenopausal women (non-hysterectomized)
- Women between 40 and 75 years of age.
- Willing to participate in the study and sign an informed consent.
- Women who have self-identified symptom(s) of vaginal atrophy.
- Willing to have endometrial biopsy at screening and end of study (Week 52).
Main Exclusion Criteria:
- Undiagnosed abnormal genital bleeding.
- Hypertension equal to or above 140/90 mm Hg.
- The administration of any investigational drug within 30 days of screening visit.
- Endometrial hyperplasia, cancer or endometrial histology showing proliferative, secretory or menstrual type characteristics at histologic evaluation of endometrial biopsy performed at screening.
Data sourced from ClinicalTrials.gov (NCT01256671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.